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NCT Number: NCT02342405

High Inspiratory Oxygen Fraction on Endothelial Function in Healthy Volunteers

The frequency of preoperative cardiac ischemia and the 30-days postoperative mortality is much higher than previously assumed, with approximately 10 % of patients undergoing non-cardiac surgery suffering from postoperative myocardial injury. A recent danish study furthermore showed that patients treated with a high inspiratory oxygen fraction during surgery had a higher 1 year mortality compared with patients treated with a low inspiratory fraction. This was especially significant among patients undergoing cancer surgery. A possible explanation, is that a high oxygen fraction results in oxidative stress and endothelial dysfunction.

With this randomized cross-over study we wish to investigate the effect of a high inspiratory oxygen fraction on the endothelial function among healthy male volunteers. The primary outcome is the endothelial function assessed by the EndoPat system. Secondary outcomes are changes in oxidative biomarkers. Heart rate variability (HRV) recordings will serve as a measure for the effect of oxygen on the autonomic nervous system.

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Key information

Conditions

Endothelial Dysfunction

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

UHKoge

Køge, 4600, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male volunteers between 18 and 30 years who has given an oral and written informed consent

Exclusion criteria

  • Smoking, or ex-smoker Any kind of medication on a daily basis History of atopic dermatitis Known familiar hypercholesterolemia History of arteriosclerotic disease in the first and second-degree relatives Known or unknown arrhythmias, as measured by the baseline HRV-recording

Treatment and study plan

80% oxygen

Other

30% oxygen

Other

Primary outcomes

  1. Endothelial dysfunction assessed by the EndoPat-system

    Time frame: After 2 hours of preoxygenation

    Changes in baseline pulse-wave-amplitude (PWA) after ischemia-reperfusion from the baseline PWA measurement until 5 minutes after ischemia as a measure of altered endothelial cell function caused by high inspiratory oxygen fractions

Secondary outcomes

  1. Heart rate variability (HRV) after ischemia-reperfusion as a measure of altered balance in the Autonomic nervous system

    Time frame: Baseline measure conducted from baseline until 20 minutes of pre oxygenation. Secondary measures is conducted 20 minutes before withdrawal of the oxygen

  2. Plasma-Malondialdehyde (MDA)

    Time frame: Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure

  3. Plasma-Arginine/Asymmetric dimethylarginine(ADMA)

    Time frame: Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure

  4. Plasma-Tetrahydrobiopterin

    Time frame: Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure

  5. Plasma-Advanced oxidation protein products (AOPP)

    Time frame: Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure

  6. Plasma-Ascorbate/Dehydroascorbate (AA/DHA)

    Time frame: Meaured at baseline, after 2 hours of oxygenation and after 30, 60, 120, 240 minutes after the EndoPat measure

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Official study title

Effect of High Inspiratory Oxygen Fraction on Endothelial Function in Healthy Volunteers: a Randomized Controlled Cross-over Trial

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 19, 2015
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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